OPERATIONS / CMC

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Simply put operations is about planning, organizing and supervising production and distribution. In essence, operations just need to work.

 

Biolegal has experience in contracting through the entire supply chain working with both CDMO's and product owners with its own in-house manufacturing capabilities.

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Below are some specific areas and examples of matters where we may assist:

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• Preparation for selection and contracting for manufacturing and supply of API and drug product (clinical and commercial),

• work orders/scopes of work, including change orders

• confidential disclosure agreements (CDA)

• material transfer agreements (MTA)

• feasibility study agreements,

• original equipment manufacturer (OEM) agreements

• third party hardware and software licensing agreements

• data processing agreements (DPA)

• agreements with strategic suppliers of key raw materials or components,

• technical/quality agreements, 

• technology transfer agreements, etc.

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